Validation of an Immunochromatographic Assay for IgG/IgM Antibodies to 2019- nCoV

  • STATUS
    Recruiting
  • participants needed
    1000
  • sponsor
    European Institute of Oncology
Updated on 19 February 2024
cancer
fever
white blood cell count
pneumonia
immunoglobulins
PCR test
respiratory distress
cough
fatigue
oximetry
covid-19
myalgia
SARS
gene sequencing
coronavirus infection
anosmia
throat
acute respiratory syndrome (sars)

Summary

In COVID-19 pandemic, it is of critical importance to identify a rapid and simple diagnostic method to be used in clinical settings to timely inform and refine strategies that can prevent, control, and stop the spread of SARS-CoV-2. The 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane-based immunoassay for the detection of immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies to SARS-CoV-2 in whole blood, serum or plasma specimen. Clinical specimens from patients who were suspected of being infected with 2019-nCoV will be used to evaluate the performance of the assay.

Description

In COVID-19 pandemic, it is of critical importance to identify a rapid and simple diagnostic method to be used in clinical settings to timely inform and refine strategies that can prevent, control, and stop the spread of SARS-CoV-2. The 2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane-based immunoassay for the detection of Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies to SARS-CoV-2in whole blood, serum or plasma specimen. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with 2019-nCoV antigen-coated particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region, if the specimen contains IgG antibodies to SARS-CoV-2. The study aims to validate in a real life study a self diagnostic assay for SARS-CoV-2 with the advantages of high speed, simple operation and low cost, and overcomes the shortcomings of the existing molecular detection methods. Clinical specimens from patients who were suspected of being infected with 2019-nCoV will be used to evaluate the performance of the assay. In parallel, we will also use molecular assays for the detection of the presence of the viral RNA from nasopharyngeal swabs since Polymerase Chain Reaction is currently the gold standard.

Details
Condition COVID
Age 18years - 100years
Treatment 2019-nCoV IgG/IgM Rapid Test Cassette
Clinical Study IdentifierNCT04434417
SponsorEuropean Institute of Oncology
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Suspected cases who meet the following 2 criteria at the same time
Epidemiological history: There was a history of contact with confirmed cases before the onset of illness; or subjects with at least one symptom in the last week before accrual in the trial. Subjects who have been in contact with people positive for SARS-CoV-2 in the previous 14 days
Clinical manifestations are defined as
Fever >37.5; dry cough, muscle pain and/or fatigue, anosmia, subjects with
respiratory distress (Respiratory Rate >25/min or O2 Saturation <92%) or
imaging characteristics of pneumonia; or the total number of white blood cells
is normal or decreased with the lymphocyte count decreased in the early stage
of onset or there is an abnormal C-Reactive protein. Other symptoms that
clinical investigator will relate to SARS-CoV-2 infection. Subject or cancer
patients who have been quarantined for suspect symptoms and have access to
hospital to continue therapy or to receive major surgery
\. Confirmed cases, namely patients or subjects with positive Reverse
Transcription-Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2. On the basis
of meeting the criteria for suspected cases, sputum, throat swabs, lower
respiratory tract secretions, and other specimens are tested by realtime RT-
PCR for positive nucleic acid detection of new coronavirus; or viral gene
sequencing is highly homologous with known new coronaviruses. Patients
positive are serially tested with SARS-CoV-2 lgM / IgG Rapid Test to evaluate
the immune response in IgG negative patients and the reliability of the test
in those patients who develop clinical signs of SARS-CoV-2 during the trial
\. Patients who are considered at high risk for infection and eligible for
active therapy and major surgery
Frailty (age and multiple comorbidities) planned to receive a standard systemic anticancer treatment comprising chemotherapy and/or immunotherapy and/or radiation therapy or to receive an experimental treatment
Major surgery or surgery after neoadjuvant chemotherapy and or chemo/radiotherapy

Exclusion Criteria

Ascertained influenza virus, parainfluenza virus, adenovirus, respiratory syncytial virus, rhinovirus, human metapneumovirus, Severe Acute Respiratory Syndrome coronavirus, and other known other viral pneumonia
Ascertained mycoplasma pneumoniae, chlamydia pneumonia, and bacterial pneumonia; non-infectious diseases such as vasculitis, dermatomyositis, and organizing pneumonia
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